Neratinib safety evaluation: real-world adverse event analysis from the FAERS database.

ABSTRACT:

Aims

Neratinib has emerged as significant theraputic option for breast cancer treatment. However, despite its approval, numerous adverse drug events (ADEs) associated to it remain unrecognized and unreported. This study aims to mine and analyze the signals of ADEs related to neratinib from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing insights for safe and rational clinical use of drug.

Methods

All the neratinib-related ADEs data were collected from FAERS database from the third quarter (Q3) of 2017 to the fourth quarter (Q4) of 2023. After standardizing the data, 4 disproportionality methods were used to assess the correlation between neratinib and ADEs.

Results

Of the 1,544 ADEs implicating neratinib as the primary su

SUBMITTER: Fan Y 

PROVIDER: S-EPMC11427278 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature